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Fourth Commission Directive of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (85/490/EEC)

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Changes over time for: Division A.

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A.IDENTIFICATIONU.K.+E.U.

1.SCOPE AND FIELD OF APPLICATIONU.K.+E.U.

This method will detect alpha-monoglyceryl 4-aminobenzoate (glycerol 1-(4-aminobenzoate). It will also detect ethyl 4-aminobenzoate (benzocaine INN) which may be present as an impurity.

2.PRINCIPLEU.K.+E.U.

This identification is done by thin layer chromatography on silica gel with a fluorescent indicator and detection of the free primary amine group by formation of a diazo dye on the plate.

3.REAGENTSU.K.+E.U.

All reagents should be of analytical purity.

3.1.Solvent mixture: cyclohexane/propan-2-ol/stabilized dichloromethane 48/64/9 (v/v/v).U.K.+E.U.
3.2.Development solvent: petroleum ether (40-60)/benzene/acetone/ammonium hydroxide solution (minimum 25 % NH3): 35/35/35/1 (v/v/v/v).U.K.+E.U.
3.3.
3.4.Standard solutions:U.K.+E.U.
  • alpha-monoglyceryl 4-aminobenzoate: 0,05 g in 100 ml of mixed solvent 3.1;

  • ethyl 4-aminobenzoate: 0,05 g in 100 ml of mixed solvent 3.1.

3.5.Silica gel 60 F254 plates, 0,25 mm thick, 200 mm × 200 mm.U.K.+E.U.
4.APPARATUSU.K.+E.U.
4.1.Normal apparatus for thin layer chromatography.U.K.+E.U.
4.2.Ultrasonic vibrator.U.K.+E.U.
4.3.Millipore filter FH 0,5 μm or equivalent.U.K.+E.U.
5.PROCEDUREU.K.+E.U.
5.1. Sample preparation U.K.+E.U.

Weigh 1,5 g of the product to be analyzed in a 10 ml stoppered graduated flask. Make up to the mark with the solvent 3.1. Stopper and leave for one hour at room temperature in an ultrasonic vibrator (4.2). Filter through a Millipore filter (4.3) and use the filtrate for chromatography.

5.2. Thin layer chromatography U.K.+E.U.

Deposit 10 μl of sample solution (5.1) and of each standard solution (3.4) on the plate (3.5).

Develop the chromatogram to a height of 150 mm in a tank previously saturated with solvent 3.2. Allow the plate to dry at ambient temperature.

5.3. Development U.K.+E.U.
5.3.1.Observe the plate under 254 nm UV light.U.K.+E.U.
5.3.2.Spray the completely dried plate with the solution 3.3 (a).U.K.+E.U.

Allow to dry at room temperature for 1 minute and immediately spray with the solution 3.3 (b).

Dry the plate in an oven at 60 oC. The spots appear an orange colour. Alpha-monoglyceryl 4-aminobenzoate: RF 0,07; ethyl 4-aminobenzoate: RF 0,55.

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